GALAXY Registry

Long-Term Evaluation of the Linox Family ICD Leads Registry


Study Design

  • Multi-center, prospective, non-randomized, 5-year data collection registry
  • Designed to confirm long-term safety and reliability of BIOTRONIK’s Linox ICD leads
  • 1,997 subjects at 98 US sites

Reference No.
  • NCT00836589
Study Objective
  • To confirm long-term safety and reliability of BIOTRONIK’s family of ICD leads, as used in conjunction with BIOTRONIK ICD pulse generators.
1° Endpoints
  • To evaluate the overall incidence of serious adverse events related to the Linox family of ICD leads.
  • To evaluate the incidence of each type of serious adverse event that contributes to Primary Endpoint 1.
2° Endpoints
  • Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment
  • Electrical characteristics of each individual Linox lead system, measured at scheduled GALAXY registry follow ups through 5 years post-enrollment
Clinical Sites
  • 98 US sites
Sample Size
  • 1,997 subjects
Inclusion Criteria
  • Successfully implanted Linox lead system connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
  • Able to understand the nature of the registry and provide informed consent
  • Available for follow-up visits on a regular basis at the investigational site
  • Age greater than or equal to 18 years
Main Exclusion Criteria
  • Enrolled in any IDE clinical study
  • Planned cardiac surgical procedures or investigational measures within the next 6 months
  • Expected to receive a heart transplant within 1 year
  • Life expectancy less than 1 year
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Pregnancy
  • Linox and Linoxsmart ICD lead systems
  • Leads must be used in conjunction with a BIOTRONIK ICD
  • At least once every 6 months per site's institutional standard of care.
Study Duration
  • Study start date January 2009. Estimated study completion November 2016.